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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033480
Receipt No. R000038176
Scientific Title The influence of snack intake and increasing physical activity to second meal effect
Date of disclosure of the study information 2018/07/24
Last modified on 2019/01/22

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Basic information
Public title The influence of snack intake and increasing physical activity to second meal effect
Acronym The influence of snack intake and increasing physical activity to second meal effect
Scientific Title The influence of snack intake and increasing physical activity to second meal effect
Scientific Title:Acronym The influence of snack intake and increasing physical activity to second meal effect
Region
Japan

Condition
Condition type2 diabetes
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the influence of snack intake and increasing physical activity to second meal effect focusing on diurnal variation of blood glucose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following measures would be conducted before and after 2 weeks intervention
1)evaluation of biological rhythm by glucose measurements by flash glucose monitoring system
Key secondary outcomes 1)Background survey
2)height
3) weight
4) body composition
5) food frequency questionnaire
6) food intake record
7)morning-eveningness type / Pittsburgh sleep quality index / physical activity questionnaire / constipation evaluation
8)physical activity measured by accelerometer or activity meter
9)blood preasure
10)bone density
11)appetite

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Acute snack intake group
Interventions/Control_2 Snack improving glucose metabolism (A) intake group
Interventions/Control_3 Ordinally snack intake group
Interventions/Control_4 Increasing physical activity group
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria Men or women in 20-80 th who agreed with research purpose meet following requirements.
1)who doesn't have change in lifestyle in intervention term
2)who can wear a glucose monitor and an action monitor, eat test meal or be more active at specific time
3)who doesnt have a custom to exercise
Key exclusion criteria 1) To take medicine related to psychotropic, sleeping, steroid
2) Obesity (BMI>35kg/m2) and sleep apnea syndrome
3) High blood pressure (SBP:above140mmHg, and DBP:above 90mmHg)
4) To take medicine related to diabetes and hyperlipidemia
5) The principal investigator or the principal doctor judge the subject as inappropriate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigenobu Shibata
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code
Address 2-2 Wakamatsu, Shinjuku, Tokyo
TEL 03-5369-7318
Email shibatas@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamiho Ozaki
Organization Waseda University
Division name Faculty of Advanced Science and Engineering
Zip code
Address 2-2 Wakamatsu, Shinjuku, Tokyo
TEL 03-5369-7318
Homepage URL
Email mo_u2@ruri.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization MEXT, MAFF
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Women's Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 23 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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